A Randomized, Two-Treatments, Two-Periods, Crossover, Open label, Laboratory-Blind, Single Dose Bioequivalence Study between Vildagliptin/Metformin 50 mg/1000 mg Film Coated Tablets (Sensityn®) and Galvusmet® 50 mg/1000 mg Film Coated Tablets in healthy adults under fed conditions

Abstract

Vildagliptin/metformin 50 mg/1000 mg film coated tablets (Sensityn®) is being developed for the treatment of type 2 diabetes mellitus. An open label, crossover, bioequivalence study (phase I) was conducted to assess the bioequivalence between Sensityn® Film Coated Tablets (Test Product/Alpha Pharma Industries, a subsidiary of Cigalah Healthcare LLC, KAEC, Saudi Arabia) and Galvusmet® Film Coated Tablets (Reference product/Novartis Pharma, Switzerland), in healthy adults under fed conditions. Safety and tolerance were evaluated as secondary endpoints.

Keywords

• bioequivalence
• diabetes mellitus
• metformin
• pharmacokinetics
• vildagliptin